MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female patient underwent a breast reconstruction with a mentor memoryshape breast implant 345cc and experienced capsular contracture baker grade iv on the right side post-operatively, which was confirmed during a physical exam.As a result, the patient underwent a capsulectomy on (b)(6) 2017.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
See h11 for correction details.Manufacturer¿s reference number: (b)(4),on (b)(6) 2021, it was noticed the previous report erroneously omitted information: patient gender was left blank.The field has been updated to female.
Additional Manufacturer Narrative
On sep 15, 2023, additional information was received indicating the patient also experienced capsular contracture baker grade iv and rupture on the left side.This report is for the right breast prosthesis.See manufacturer report number 1645337-2023-11847 for contralateral side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On oct 12, 2023, additional information was received indicating the adverse event reported for the contralateral (left) side was reported in error.There were no issues experienced by the patient on the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On oct 29, 2024, additional information was received indicating the patient experienced rupture on the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On dec 10, 2024, additional information was received indicating the patient experienced capsular contracture baker grade iv on the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On feb 14, 2025, it was noticed the date of explantation (b)(6) 2022) was erroneously omitted from the previous reports.The field has been updated appropriately.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On jul 1, 2025, additional information was received indicating the patient also experienced an infection on the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On jan 8, 2026, additional information was received indicating the capsular contracture baker grade is grade iii bilaterally.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On feb 27, 2026, additional information was received indicating the date of event was may 31, 2017.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12025432
• Report Number: 1645337-2021-06948
• Device Sequence Number: 3673794
• Product Code: FTR
• UDI-Device Identifier: 00081317005193
• UDI-Public: 00081317005193
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2021
• Device Model Number: 3341152
• Device Catalogue Number: 3341152
• Device Lot Number: 7406457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 09/15/2023; 10/12/2023; 10/29/2024; 12/10/2024; 02/14/2025; 07/01/2025; 01/08/2026; 02/27/2026
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 06/23/2021; 10/05/2023; 11/01/2023; 11/26/2024; 01/02/2025; 03/05/2025; 07/25/2025; 01/29/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 160 LB
• Patient Race: White